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临床试验/NCT04595851
NCT04595851终止不适用

Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)

University of Michigan Rogel Cancer Center2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
PDC for chronic condition medications

研究概览

简要总结

The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care practices (Pharmacists Coordinated care Oncology Model [PCOM]).

This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Has primary care physician
  • Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
  • Initiating an OAA, either for the first time or a change from previous OAA
  • Diagnosis of at least 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease
  • Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.
  • Willing and able to sign informed consent.

排除标准

  • Cannot speak English
  • Concurrent diagnosis of type 1 diabetes
  • Concurrent diagnosis of human immunodeficiency virus

结局指标

主要结局

PDC for chronic condition medications

时间窗: Up to 6 months following OAA initiation

PDC is the ratio of the number of days the patient is supplied with chronic condition medications, from the time of OAA initiation until 6 months later, to the total number of days during that period.

Dose-adjusted proportion of days covered (PDC) for oral anti-cancer agent (OAA)

时间窗: Up to 6 months following OAA initiation

PDC is a common way to assess a patient's adherence to a medication regimen. PDC is the ratio of number of days the patient is supplied with OAA medication, from the time of OAA initiation until 6 months later, to the total number of days during that period. For OAAs, data from the electronic medical record (EMR) for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.

次要结局

  • Percent of patients with completed Comprehensive Medication Reviews (CMRs)(Day 50 (+/-3) after OAA initiation)
  • Percent of patients with scheduled Comprehensive Medication Review (CMR) within one week of first PROM result(Day 22 (+/-3) after OAA initiation)
  • Percent of CMRs where note was routed to oncology pharmacist(Up to day 43 (+/-3) after OAA initiation)
  • Percent of patients with two completed Patient Reported Outcome Measures (PROMs)(Up to day 42 (+/-3) after OAA initiation)
  • Percent of patients where oncology pharmacist reviewed PROM within 1 day of receiving scored PROM(Up to day 44 (+/-3) after OAA initiation)
  • Percent of CMR notes that oncology pharmacist reviewed(Up to day 44 (+/-3) after OAA initiation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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